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Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity (SUD/Anx)

Primary Purpose

Other (or Unknown) Substance Use Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy (Anxiety Sensitivity Intervention)
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Other (or Unknown) Substance Use Disorders focused on measuring Substance Use Disorders, Anxiety, Anxiety Sensitivity, Brief Intervention, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • score higher than 25 (established clinical cutoff) on the Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999)
  • meet the DSM diagnostic criteria for current substance abuse or psychological dependence

Exclusion Criteria:

  • active psychosis, suicidality, mania, or current physiological withdrawal symptoms that necessitate medical detoxification; no substance use in the past 3 months

Sites / Locations

  • Institute of Living/Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Anxiety Sensitivity Intervention

Control Group

Arm Description

Group receives the 3-week, 6-session Anxiety Sensitivity Intervention. This is a 6-session psychotherapy occurring twice weekly (60-90 minutes) for three weeks. This psychotherapeutic treatment is focused on reducing anxiety sensitivity and includes many components, but primarily consists of psychoeducation about the relationship between anxiety and substance use disorders, interoceptive exposures, in vivo exposures, and cognitive challenging.

Receives only treatment as usual

Outcomes

Primary Outcome Measures

Change in total score on Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999), from baseline (pre-treatment) to ASI score at 3-months post-treatment.
The ASI is a self-report measure consisting of 16 questions which ask about past-week fear of physical and psychological symptoms of anxiety and fear of potential sequelae of anxiety (e.g., "When I notice my heart is beating rapidly, I worry that might have a heart attack"; or "When my stomach is upset, I worry I might be seriously ill"). Scores over 25 are suggestive of clinically significant anxiety sensitivity (Peterson & Plehn, 1999).
Change in Percent Days Abstinent over the past 30 days on the Timeline Follow-Back (TLFB; Sobell & Sobell, 1996), from Pre-treatment to 3-months post-treatment.
The TLFB is an interview which asks patients to retrospectively report on daily drinking quantity and frequency for the past 30 days. Using a calendar, the interviewer asks the respondent to identify important holidays and other memorable events over the retrospective time window, and then uses these events to help cue the respondent's memory of alcohol /drug use quantity and frequency over this period. Using these prompts and the respondent's knowledge of his/her own drinking/drug use patterns, an report of types of drug used and estimates of quantity of use is obtained for each day in the window. In the current study, the baseline and follow-up TLFBs covered the past 90 days; the post-treatment TLFB covered the past 30 days.

Secondary Outcome Measures

Change in total score on Depression, Anxiety, and Stress Scales (DASS; Brown, Chorpita, Korotitsch, & Barlow, 1997).
The DASS is a 21-item self-report questionnaire which provides total scores for anxiety, depression, and stress subscales. The Depression scale assesses symptoms of dysphoria, hopelessness, devaluation of life, self-deprecation, anhedonia, lack of interest/involvement, and inertia. The Anxiety scale assesses symptoms of autonomic arousal, skeletal musculature effects, situational anxiety, and subjective experience of anxious affect. The Stress scale assesses symptoms of difficulty relaxing, nervous arousal, agitation, irritability/over-reactivity, and impatience. The DASS queries about symptoms in the past week and therefore outcome will be change in total score from pre-treatment to 3 months post-treatment.

Full Information

First Posted
September 5, 2014
Last Updated
March 25, 2016
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02667015
Brief Title
Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity
Acronym
SUD/Anx
Official Title
Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the current study is to develop and pilot test an anxiety sensitivity-based intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions include determining whether a broadly-applicable AS-based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In phase I, an initial pilot was conducted to examine the feasibility, safety, and patient satisfaction with the protocol, and to estimate potential efficacy of the protocol. In phase II, participants will be randomized to the intervention or a control condition.
Detailed Description
The aim of the current study is to develop and pilot test an anxiety-sensitivity based intervention for co-occurring SUDs and anxiety. In the proposed study, the investigators will develop, refine, and pilot-test an innovative cognitive-behavioral therapy (CBT) for patients who suffer from substance use disorders as well as anxiety. The goal of the research group in the proposed study is to design a protocol that can be testable on a larger sample within an externally-funded, randomized controlled trial. The investigators plan to submit a proposal for this larger grant to the National Institute on Drug Abuse, as outlined in our external funding statement. Research questions include determining whether a broadly-applicable anxiety sensitivity based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In this translational research project, strategies that have been demonstrated to impact the psychological mechanisms thought to underlie both illnesses will be tested in a "real world" clinical setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other (or Unknown) Substance Use Disorders
Keywords
Substance Use Disorders, Anxiety, Anxiety Sensitivity, Brief Intervention, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxiety Sensitivity Intervention
Arm Type
Experimental
Arm Description
Group receives the 3-week, 6-session Anxiety Sensitivity Intervention. This is a 6-session psychotherapy occurring twice weekly (60-90 minutes) for three weeks. This psychotherapeutic treatment is focused on reducing anxiety sensitivity and includes many components, but primarily consists of psychoeducation about the relationship between anxiety and substance use disorders, interoceptive exposures, in vivo exposures, and cognitive challenging.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receives only treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy (Anxiety Sensitivity Intervention)
Intervention Description
3 week, 6-session psychotherapy targeting anxiety sensitivity
Primary Outcome Measure Information:
Title
Change in total score on Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999), from baseline (pre-treatment) to ASI score at 3-months post-treatment.
Description
The ASI is a self-report measure consisting of 16 questions which ask about past-week fear of physical and psychological symptoms of anxiety and fear of potential sequelae of anxiety (e.g., "When I notice my heart is beating rapidly, I worry that might have a heart attack"; or "When my stomach is upset, I worry I might be seriously ill"). Scores over 25 are suggestive of clinically significant anxiety sensitivity (Peterson & Plehn, 1999).
Time Frame
Pre, Post, 3-month follow-up
Title
Change in Percent Days Abstinent over the past 30 days on the Timeline Follow-Back (TLFB; Sobell & Sobell, 1996), from Pre-treatment to 3-months post-treatment.
Description
The TLFB is an interview which asks patients to retrospectively report on daily drinking quantity and frequency for the past 30 days. Using a calendar, the interviewer asks the respondent to identify important holidays and other memorable events over the retrospective time window, and then uses these events to help cue the respondent's memory of alcohol /drug use quantity and frequency over this period. Using these prompts and the respondent's knowledge of his/her own drinking/drug use patterns, an report of types of drug used and estimates of quantity of use is obtained for each day in the window. In the current study, the baseline and follow-up TLFBs covered the past 90 days; the post-treatment TLFB covered the past 30 days.
Time Frame
Pre, Post, 3-Month Follow-Up (measure queries past 30 days only at these time points)
Secondary Outcome Measure Information:
Title
Change in total score on Depression, Anxiety, and Stress Scales (DASS; Brown, Chorpita, Korotitsch, & Barlow, 1997).
Description
The DASS is a 21-item self-report questionnaire which provides total scores for anxiety, depression, and stress subscales. The Depression scale assesses symptoms of dysphoria, hopelessness, devaluation of life, self-deprecation, anhedonia, lack of interest/involvement, and inertia. The Anxiety scale assesses symptoms of autonomic arousal, skeletal musculature effects, situational anxiety, and subjective experience of anxious affect. The Stress scale assesses symptoms of difficulty relaxing, nervous arousal, agitation, irritability/over-reactivity, and impatience. The DASS queries about symptoms in the past week and therefore outcome will be change in total score from pre-treatment to 3 months post-treatment.
Time Frame
Pre, Post, 3-month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: score higher than 25 (established clinical cutoff) on the Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999) meet the DSM diagnostic criteria for current substance abuse or psychological dependence Exclusion Criteria: active psychosis, suicidality, mania, or current physiological withdrawal symptoms that necessitate medical detoxification; no substance use in the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blaise l Worden, Ph.D.
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living/Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06061
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity

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